ComplianceHome: FDA Events

CDRH's NumberOne Priority Are You Prepared?

Mon, 21 Jul 2008 00:00:00 CST

2008-07-31 None
Sign up your entire team to listen in and discover:

* The nuts and bolts of the FDAs postmarket surveillance authority under the FDAAA
* How postmarket surveillance compares with postapproval studies
* When and how postmarket surveillance can be imposed
* Three pitfalls to avoid when preparing for postmarket surveillance
* Strategies for meeting regulatory expectations for complying with postmarket surveillance requirements
* 10 critical details to include in a postmarket surveillance plan
* The role of postmarket surveillance in the bigger picture of the FDAs Postmarket Transformation Initiative
* Potential consequences of noncompliance
* Four ways postmarket surveillance impacts other key FDA compliance requirements

Compliance Boot Camp 2008 : Validation, Quality and Compliance Training

Fri, 11 Jul 2008 00:00:00 CST

2008-09-22 - 2008-09-26 None
You'll learn:

* Which validation deliverables the FDA expects and what they should contain
* How to identify, document and report computerized system validation deviations
* How the FDA defines a systems risk and mitigation strategy that you can deploy
* Proactive steps you can take to avoid CSV and Part 11 Form 483s and warning letters
* The five supporting pillars required for effective CSV, including: system management and monitoring, system change management, risk management, vendor management and CSV methodology management
* Update on the new draft Part 11 regulation

Navigating the FDA's New Requirements for eCTD Submissions

Mon, 07 Jul 2008 00:00:00 CST

2008-07-28 - 2008-07-29 Philadelphia, PA
n Navigating the FDA's New Requirements for eCTD Submissions, you will:

* Discover the top 10 reasons sponsors receive a refuse-to-file from the FDA on their eCTD submissions
* Gain clarity on the acronyms and jargon of eCTD and electronic submissions
* Effectively budget and develop project plans for eCTD submissions
* Understand why and how to start producing eCTD submissions at the IND phase
* Master the documentation requirements for electronic datasets for stability, nonclinical and clinical, and better communicate these requirements to colleagues early in the drug development cycle
* Assure the output of your in-house system is valid for FDA review
* Learn about the eCTD pilot what it does, why you need it, how it works and how to make it work for you
* Learn about the FDA's Electronic Submissions Gateway and how to prepare to submit your eCTDs electroni